Creatinine clearance (CLcr, measured or calculated) \>80 mL/min; and
Life expectancy of at least 12 weeks;
Fully recovered from the acute effects of prior cancer therapy: 4 weeks for chemotherapy (8 weeks for mitomycin C or nitrosoureas), 10 days for prior palliative radiation therapy or hormonal therapy, and 4 weeks for prior immunotherapy or other biologic therapy; and
Signed written informed consent.
Patients having reproductive potential who are not using an effective method of birth control or who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test during baseline;
Known sensitivity to immunomodulating agents or monoclonal antibodies;
Alcohol abuse or illicit drug use within 12 months of enrollment;
History of serum creatinine ≥2 mg/dL for any duration and for any reason;
Patients, other than menstruating females, with urine dipstick 1+ or more positive for blood or 2+ or more positive for protein;
Patients with clinically significant presence of granular or cellular casts in centrifuged urine sediment;
Patients with renal carcinoma or renal metastases;
Patients that have had a partial or complete nephrectomy;
Patients requiring dialysis (peritoneal or hemodialysis);
Prior treatment with Amphotericin B or cisplatin;
Patients with history of insulin-dependent diabetes for greater than 5 years;
Concomitant treatment with systemic high dose corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline;
Concomitant treatment with anticoagulants, such as coumadin or heparin, except to maintain patency of in-dwelling catheters;
Prior allergic reactions attributed to compounds of similar chemical or biologic composition to study drug (eg, rituximab or immunoglobulin G);
Ongoing or active infection;
Required the use of systemic antibiotics or antifungals for ongoing or recurrent infections.
Topical use of antibiotics or antifungals is allowed;
Other uncontrolled concurrent illness that would preclude study participation; or
Psychiatric illness or social situation that would preclude study participation.
You may not be if
Previously treated with any other agent that targets CD40;
Concurrent treatment with any anticancer agent;
History of autoimmune disorder, including pemphigus vulgaris, systemic mastocytosis, systemic lupus erythamatosus, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen's syndrome, vasculitis/arteritis, Behcet's syndrome, inflammatory boweldisease, autoimmune thyroiditis, multiple sclerosis, or other chronic inflammatory disease;
Treatment with any other investigational therapy within 4 weeks prior to baseline;
History (within the previous year) of congestive heart failure, stroke, or myocardial infarction;
Patients with known hereditary or acquired coagulopathies (eg. hemophilia, von Willebrand's disease, cancer-associated DIC, abnormal D-dimer);
